SAFETY OF AUTOLOGOUS MARROW STROMAL CELLS AFTER STROKE

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 研究项目简介--这项研究将是一项I期剂量递增试验，以评估在急性缺血性中风患者中输注自体间充质基质细胞(MSC)的安全性。中风仍然是美国成人残疾的主要原因。大多数患者没有足够早地获得医疗保健，无法从超急性中风疗法中受益。在中风的动物模型中，在脑梗塞后几天给予MSC与改善行为结果有关。在几项对患有非脑血管疾病的人类的安全性研究中，MSC被发现是安全的。因此，MSC可能代表了一种治疗方法，可以改善人类中风患者的预后，并提供广泛的干预时间窗口。 具体目标将根据特定的主要和次要终点评估接受这种治疗的患者的发病率和死亡率是否高于预期。主要终点集中在治疗90天后的死亡率和主要血栓形成/感染性不良事件。次要终点从更长远的角度考虑这些事件，并进一步评估对全身和神经功能的潜在不良影响。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. BRIEF EXPLANATION OF RESEARCH PROJECT--This study will be a Phase I dose-escalation trial to evaluate the safety of autologous mesenchymal stromal cell (MSC) transfusion in patients with acute ischemic stroke. Stroke remains the leading cause of adult disability in the U.S. Most patients do not access healthcare early enough to benefit from hyperacute stroke therapies. In animal models of stroke, administration of MSC days after infarct has been associated with improved behavioral outcome. MSC have been found to be safe in several safety studies of humans with non-cerebrovascular diagnoses. MSC may therefore represent a treatment that can improve outcome in human stroke patients with a wide time window for intervention. The specific aims will evaluate whether the morbidity and mortality rates among patients receiving this treatment are higher than expected according to specific primary and secondary endpoints. The primary endpoint focuses on mortality and major thrombotic/infectious adverse events 90 days after treatment. The secondary endpoints consider these events over a longer term, and further evaluate potential adverse effects on systemic and neurological function.